Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Tisteron Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tisteron Ltd.
ClinicalTrials.gov Identifier:
NCT01066117
First received: February 4, 2010
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

The purpose of the proposed study is to test the effect of the new gel pad on the quality of life of urinary incontinent men and women and to assess to what extent the gel pad improves the quality of life of incontinence persons.


Condition Intervention
Urinary Incontinence
Other: PeeRelease gel absorbent pad

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence Over Existing Solutions

Resource links provided by NLM:


Further study details as provided by Tisteron Ltd.:

Primary Outcome Measures:
  • Significant improvement in quality of life for men and women who use the new gel pad in comparison to usage of existing solutions; this means a difference of at least 5 scores on the 1-100 I-QoL score scale [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pad weight and number of pads used per day [ Time Frame: daily ] [ Designated as safety issue: No ]
  • Observation for any development of rash due to patients' sensitivity to the pad [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: February 2010
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: PeeRelease gel absorbent pad
    A larger gel containing pad was developed, suitable to absorb up to half a liter liquid, it eliminates odors and enables the users to wear ordinary clothes
Detailed Description:

The devices available today on the market serve two polar incontinence conditions: those who have severe urinary incontinence and need to use diapers several times per day, or those who have mild urinary incontinence and can use pads.

Such circumstances call for a search of new solution that may provide the benefit of freeing those with moderate incontinence from changing pads several times a day or staying constantly very near a bathroom, as well as freeing those with severe incontinence from using cumbersome diapers.

A larger gel containing pad was developed, suitable to absorb up to half a litter liquid, it eliminates odors and enables the users to wear ordinary clothes . It was presented for clinical trial.

The objectives of the clinical trial, proposed hereafter is to assess to what extent the new gel pad presents an advantage over the existing means of coping with urinary incontinence in cases when medicinal treatment or surgery is not appropriate.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Urinary incontinent women and men who loose urine at a quantity higher than drops (50CC or more).
  2. Three segments of such persons will be included in the study:

    • pregnant women who are temporary urinary incontinent
    • women of the age 40+ who are urinary incontinent
    • men who are urinary incontinent (post prostatectomy)

Exclusion Criteria:

  1. Urinary incontinent disabled patients who need nursing
  2. Patients who presently have cancer of any kind,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066117

Locations
Israel
Rabin Medical Center Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Bari Kaplan, MD    97235355828    prof@barikaplan.com   
Principal Investigator: Bari Kaplan, MD         
Sponsors and Collaborators
Tisteron Ltd.
  More Information

No publications provided

Responsible Party: Tisteron Ltd
ClinicalTrials.gov Identifier: NCT01066117     History of Changes
Other Study ID Numbers: 5481
Study First Received: February 4, 2010
Last Updated: February 9, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by Tisteron Ltd.:
urinary incontinent

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014